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The Safety Blood Collection Sets for Single Use and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

The Safety Blood Collection Sets for Single Use are used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately the following venipuncture to aid in the protection against accidental needlestick injury. The Safety Blood Collect Sets is compatible for use with a tube and syringe. The product is to be used by appropriately trained healthcare professionals, only following the product instructions. The Blood Collection needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect to the needle holder, which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber cap and a needle holder. The opposite end of the needle is 3/4" long for withdrawing blood and is fitted with a needle sheath. The needle holder and needle sheath protect the needle. The safety feature is operated through the release of a latch mechanism whereby the user slides a winged cover over the needle, as it is removed from the patient. Once the needle is covered, the safety cover locks in place. This mechanism is substantially equivalent to the predicate device. The proposed devices are packaged as sterile, single-use, and single patient use only. The proposed device consists of ten components: 1. needle holder 2. rubber sleeve 3. puncture needle 4. needle hub (male luer lock connector) 5. connect base (female luer lock connector) 6. flexing tube 7. safety shield 8. wings 9. patient-end tube needle 10. needle sheath

The provided text is a 510(k) summary for a medical device (Safety Blood Collection Sets for Single Use). It details the device's characteristics, comparison to a predicate device, and various performance, biocompatibility, and sterility tests conducted. However, it does NOT describe a study that proves the device meets specific acceptance criteria in terms of AI or algorithm performance, nor does it involve human readers, expert consensus for ground truth, or an MRMC study.

The document discusses "acceptance criteria" only in the context of the physical and biological testing of the blood collection set (e.g., sterilization, biocompatibility, mechanical performance). It explicitly states: "No clinical study is included in this submission." This type of 510(k) submission generally relies on demonstrable substantial equivalence to a legally marketed predicate device through non-clinical testing, rather than novel clinical performance studies involving human subjects or AI algorithms.

Therefore, many of the requested bullet points, particularly those related to AI/algorithm performance, human readers, sample sizes for test/training sets for AI, ground truth establishment for AI, and MRMC studies, are not applicable to the content of this document.

I will address the applicable parts based on the provided text, and explicitly state when information is not present or not relevant to the document's content.

Description of Acceptance Criteria and Proving Device Meets Them

The document describes the acceptance criteria in the context of various performance, biocompatibility, and sterility tests for a physical medical device (blood collection set). It does not pertain to the performance of an AI/algorithm-based device.

1. A table of acceptance criteria and the reported device performance:

The document states that "All of the pre-determined acceptance criteria were met" for various tests, but it does not provide a specific table with the acceptance criteria values alongside numerical performance results for the device. It generally states compliance with relevant ISO and ASTM standards.

Here's a summary of the stated compliance:

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The Safety Blood Collection Set and blood collection tube/syringe are used together for the collection of venous blood. The winged needle is designed with a safety shield which can be activated to cover the needle immediately following blood collection to aid in the protection against accidental needlestick injury.

The Safety Blood Collection Set is used in routine venipuncture procedures. The winged needle is designed with a safety shield, which can be activated to cover the needle immediately following venipuncture to aid in the protection against accidental needlestick injury. The product is to be used by appropriately trained healthcare professionals.

The Blood Collection Needle is manufactured from tubular stainless steel sharpened at both ends that is attached to the hub. The hub is threaded on one side to connect with the needle holder which is used to guide the needle into an evacuated blood collection tube. This end of the needle is the shorter end and is fitted with a protective rubber sleeve and a hard plastic needle cap. The opposite end of the needle is ¾" for withdrawing blood and is fitted with a color coded hard plastic needle cap. The two needle caps protect the needle and maintain the sterility. The seal between the two needle caps is covered with a perforated paper label that permits identification and acts as a seal integrity.

The Safety Blood Collection Set is delivered sterile and is intended for single use only.

This document describes the premarket notification (510(k)) for the Jiangsu Shenli Medical Production Co., Ltd.'s Safety Blood Collection Set (K163093). The document primarily focuses on establishing substantial equivalence to a predicate device, the Improsafe Blood Collection Set (K123987), rather than a detailed study proving the device meets specific acceptance criteria through a clinical or performance study with human readers or AI.

Therefore, much of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) is not applicable to this type of submission, which relies on demonstrating equivalence through technical characteristics and compliance with standards.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All of the pre-determined acceptance criteria were met," but it does not provide a table with specific quantitative acceptance criteria alongside corresponding test results. It lists the types of performance tests conducted.

2. Sample size used for the test set and the data provenance

• Sample Size: This document does not specify the sample sizes used for each of the performance tests listed. For typical device clearance, these would be engineering tests, not clinical studies with human participants.
• Data Provenance: The tests were performed to demonstrate substantial equivalence for a device manufactured by Jiangsu Shenli Medical Production Co., Ltd. (China). The data would therefore originate from testing conducted by or for this company, likely in China or by contracted laboratories. The nature of these tests is retrospective in the sense that they were conducted on already manufactured devices to demonstrate compliance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable to this type of device submission. The "ground truth" here is compliance with established engineering standards and design specifications, verified through laboratory testing, not expert interpretation of medical images or conditions.

4. Adjudication method for the test set

This information is not applicable. Adjudication typically refers to the resolution of conflicting expert opinions in clinical studies. For engineering performance tests, results are usually compared against predefined objective criteria.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable. This submission is for a physical medical device (blood collection set), not an AI-powered diagnostic tool. Therefore, MRMC studies and AI effect sizes are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable, as the device is not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the device's performance is adherence to established national and international standards for medical devices (e.g., ISO 7864 for needles, ISO 10993-1 for biocompatibility) and its own design specifications. This is confirmed through laboratory and engineering testing.

8. The sample size for the training set

This information is not applicable, as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

This information is not applicable, as this is not an AI/machine learning device.

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